Signs
that a serious rebellion was gathering from over-regulation issues in the EU
cosmetics sector, started to become apparent with reaction to the somewhat naïve
SCCP Opinion SCCP/0942/05,which further
backed a proposal to limit furanocoumarin (FCF) concentrations in cosmetic
products down to 1ppm, citing ten commonly used citrus oils, plus rue oil
(rarely used in fragrances). It soon transpired that perfumers were unaware of
the FCF concentrations of their common (citrus) ingredients, producers were
failing to provide the relevant data, ‘FCF-free’ products were revealed as
actually not being FCF-free, leading perfume chemists in disagreement as to
whether FCF’s were actually steam volatile and that the data on alleged toxicity
of FCF’s was incomplete. Cropwatch also pointed out to the Head of Unit of the
EU Cosmetics Sector that FCF’s occur in a large number of fragrance ingredients
other than those few set out in the SCCP Opinion. Further, few aroma companies,
apart from the industry dinosaurs, could not afford the equipment and analysis
time to determine FCF ingredient concentrations. To sum up the proposal was, in
fact, amonumental
regulatory cock-up,
with executives of leading cosmetics companies muttering in corridors together,
vowing they would quietly ignore any subsequent legislation regarding the issue.

Since then matters can
only have worsened. The BFA meeting notes (14.12.06) are believed to reflect
some EFFA ideals, viz. that ‘essential oil producers should produce low
levels of isopimpinellin & bergamottene (they meant bergamottin) in purified
oils. So this is thought feasible? Oh really? We can name plenty of economically
disadvantaged essential oil producers from undeveloped areas who will not be
able to do this, so this looks like yet another good-old EU Cosmetic sector
economically divisive policy may be coming out again soon. Up to now, of course,
FCF reduction processes have produced organoleptically inferior aroma
ingredients with poor keeping qualities.

The naming and shaming
policy announced by IFRA, for erring members who have produced marketed
fragrances which contain banned or restricted ingredients at concentrations
which contravene their Standards, needs countering. Cropwatch therefore intends
to name and shame those regulatory officials who:

1. Have imposed
unreasonable restrictions on natural ingredients to the detriment of the
perfumery art and to the denial of the basic freedom to use natural aromatic
materials

2. …or have been
particularly instrumental in causing economic hardship to natural ingredient
producers & the local social infra-structure that depends on this commerce

3. … or have damaged
the eco-system via any ill-thought-out policies.

Events have now moved
on even further, however, with the controversial matter of the Cropwatch Boycott
of the 40th IFRA Amendment to its CoP, an account of which is set out
below. The authoritarian stance, secretive nature and membership exclusivity of
the private little Brussels circle which determines our freedoms to use natural
aromatic raw materials needs to be overhauled, and a more
democratically-orientated process substituted, as angry end-users have indicated
(see comments at http://www.ipetitions.com/petition/ifra40/signatures.html)..

1. IFRA’s reaction
(IFRA 2007). to Cropwatch’s Boycott of the 40th Amendment to its CoP
was posted on the IFRA website on 19th Jan 2007. You will see that
the anonymous staff writer who penned the piece has not addressed anyof the
original proffered arguments (see Burfield 2007), but merely offers a
safety-orientated justification of the QRA approach in all of its associated
complexity, from what is emerging as IFRA’s extremely narrow perspective of the
fragrance world. The unidentified writer goes on to give us a lecture on IFRA’s
exclusively privileged working arrangements, and maintains the line that IFRA’s
main purpose is “to promote the safe enjoyment of fragrances worldwide”. Any
master perfumer will quickly confirm that the enjoyment of fragrances per se
has been all but been destroyed by IFRA / EU Cosmetic sector ingredient
restrictions over the years, and IFRA cannot failed to have noticed the many
comments made by senior players in this profession featuring in the trade press,
making precisely this same observation. Any independent-minded person can only
assume that IFRA is either unworldly about the consequences of its own policies,
or chooses deliberately not to respond to such criticism.

2. Cropwatch’s
on-line petition against the 40th
IFRA Amendment is running at
http://www.ipetitions.com/petition/ifra40/
and at this point in time is over 650 signatories. It will be formerly presented
to IFRA when we believe we have contacted all those widely dispersed parties,
either directly or indirectly affected by the knock-on effects of IFRA’s
policies. The depth of feeling and the arguments that signatories have expressed
about certain issues surrounding this topic is well worth checking out (see
petition comments section
http://www.ipetitions.com/petition/ifra40/signatures.html).

3. Perfumer &
Flavoristran an IFRA vs.
Cropwatch poll on the 40th Amendment Boycott issue. The results
announced on 7th Feb 2007
gave Cropwatch a landslide victoryat85.1%of the
votes cast, to IFRA’s13.4%. The result can be viewed at
http://www.perfumerflavorist.com/newsletter/5620826.html. Cropwatch understands
from Jed Gleason at Allured that the poll will be reopened very shortly for a
further period, the next results to be featured on the P&F website on 7th
March 2007.

4. Media Reaction to
Cropwatch Boycott. This story was well reported in general, but some of the
media which normally run Cropwatch articles have not run this particular story.

5. Artisan Natural
Perfumers Guild (ANPG)
have issued a press release on 8th Feb 2007 fully supporting
Cropwatch on this issue (see full text at http://artisannaturalperfumers.org/cropwatch_ifra.htm)
and asking for a moratorium on the 40th Amendment implementation
until the policy process can be opened up and given the opportunity for a more
widespread public debate. The ANPG have constructed, together with some
international-based help, a 19 point FAQ on which can be viewed at
http://artisannaturalperfumers.org/cropwatch_ifra.htm,
which more fully explains some basic issues around this matter. Cropwatch is
pleased to see declarations on this issue from the ANPG, who represent a
formerly unheard (and as far as some are concerned, probably an unrecognised-)
sector of the perfumery spectrum.

Cropwatch Comments.

As a few Cropwatch
supporters have remarked, cosmetics & natural
products regulation in Europe up to now has been all about money.
Now the worm is turning, and hopefully there are signs that it should become
all about
democracy.
Only this week are reports of the UK government being visibly shaken by the
power of public opinion – over 1 million people have signed a Downing Street e-petition
website about road user charging (Oliver 2007). Although this latter figure
belittles the 650-odd signatures collected so far by Cropwatch from those
affected by IFRA policies over the 40th Amendment, the principle
remains the same. The power of opinion means that no longer can undiscussed,
uncriticised & unchallenged precautionary principle-based policies dreamed up by
toxicologists & EU lawyers, be allowed to dominate the regulation of the
fragrance & essential oil industries, as these regulations are slowly strangling
standards, creativity & freedom in fragrance creation & usage.

It is a fact that
reading the restricted membership mails from officials of EFFA, RIFM, IFRA etc.,
that these people quite precociously regard & term themselves, as “the industry”
– and lay people would be shocked by this arrogance, we are quite` sure. In
fact, of course, they are not the whole industry. They are merely a
seriously-advantaged part of it.

Over the past few weeks
a group of us, from househusbands to doctors & professors, have started to look
more closely at the science behind various RIFM reports, IFRA policies, articles
in Contact Dermatitis, SCCP Opinions etc. We are starting to ask
questions about the quality of science put forward & the basis of the decisions
taken, and a sense of extreme frustration is developing that the valid opinions
of any persons outside of these privileged ‘expert’ committees, or trade
associations,. counts for absolutely nothing. Something has to change before
fragrance regulation descends into anarchy, based on lack of respect for
regulatory decisions, which are both impractical (e.g. the on-going FCF issue),
unenforceable (internet sales; the myriad numbers of small cosmetics & essential
oil producers), not believable (such as the long running 26 allergens issue), or
require staff & equipment beyond the economic reach of small companies (red tape
& various analytical issues). .An initiative needs to be made by regulatory
authorities before disaffected groups make up their own more realistic &
down-to-earth Codes of Health & Safety Practice.

It
is possibly a truism that academics, toxicologists etc. researching the effects
of natural products have never had their work widely criticized, except perhaps
by their own peers. There are signs that things are changing, as a more informed
public follow their own callings & interests, and gain an increased access to
scientific literature via the media & the Internet etc. and start to ask awkward
questions. This is in contrast to the attitude of the popular media, which seems
to take an obscene delight in publishing anything which puts alternative
medicine & natural products in a bad light without questioning the robustness of
the data behind the stories.

A case in point is
illustrated by the latest work from Derek Henley and his chums who have produced
a hypothesis (Henley et al. 2007) allegedly linking the application of
cosmetics containing lavender & tea tree oils to the development of prepubertal
gynecomastia in 3 young boys who exhibited normal hormone levels for their age.
This link is, again allegedly, ‘supported’ by in vitro experiments where
lavender & tea tree oils turned on estrogen-regulated genes and inhibited an
androgen-regulated gene in the human breast cancer line MCF-7. This story has
been very widely featured in the media at face value, with almost no
investigative reporting.

Henley et al.
do not satisfactorily prove cause and effect for any identified substances in
the applied cosmetics, nor have they isolated, analysed & authenticated the
manufacturer’s claim for the alleged presence of essential oil ingredients as
being 100% derived from the named botanical source. The minute doses of essential oils received by the boys, derive
from the low concentrations allegedly present in the soap, shampoo (products
which are washed off the skin), hair gel & and the leave-on fragranced lotion -
although the latter (reportedly) did not affect the twin of one of the affected
boys in the study when used just by itself.

Many activists have
been looking further into this matter, and new information is shared between
interest groups on a daily basis. For example the Randall Neustaedter
Natural Health Newsletter refers to an article (Neustaedter 2007) which
identifies the manufacturer of the hair gel & shampoo (allegedly via information
from Clifford Bloch, the pediatric endocrinologist from Denver) which caused the
problem for all 3 boys as, again allegedly, being manufacturing under the Paul
Mitchell brand name. This product is apparently supposed to contain both lavender
and tea tree oils, although the above cited Newsletter reports that an
analysis found little evidence of the presence of tea tree oil in the cosmetics.

A particularly galling
aspect to natural product sympathisers, is to be found at end of the Henley paper. Here one of the authors, Clifford Bloch, reports
receiving grant support and lecture fees from Eli Lilly, Genentech, Novo Nordisk,
Pfizer, Tercica, & Serono, and the rider is added that “No
other potential conflict of interest relevant to this article was reported”.
Given that a considerable proportion of natural product end-users popularly
believe that pharmaceutical & chemical companies are funding negative
campaigning to put competitive natural products in a bad light, this quite
remarkable declaration will appear, rightly or wrongly, as an English
‘two-fingered salute’ to many in the essential oil industry. Cropwatch believes
that further
totally independent-based investigation to further establish or to disprove this
tenuous hypothesis is urgently needed here.

Assuming for a moment
that the conclusions of the paper are scientifically proven, and not a spoof as
has been unkindly suggested, then the situation leaves many questions unanswered
– essential oils components are only bioavailable here via skin absorption or by
the inhalation of volatiles, and we know from previous animal studies that that
the concentrations of the major components of lavender oil at least (linalool
and linalyl acetate) where inhaled via a pre-dosed air supply, can not only be
easily determined (Jirovetz et al. 1991), but can also proven to be
rapidly eliminated from the bloodstream. Nevertheless, from many studies, we
know that even at these minute levels, blood-borne lavender oil volatiles can
affect cognition skills (e.g. Sakamoto et al. (2005). In vitro
dermal bioaccumulation & elimination studies for linalool & linalyl acetate have
been conducted by Cal & Sznitowska (2003), and for the dermal penetration
considerations for tea tree oil, the studies of Cal et al. (2006),
featuring skin absorption & elimination of terpinen-4-ol might be relevant. From
these studies we can speculate that depending upon their chemical structure,
terpene bioaccumulation in the dermal layers does not in all cases necessarily
indicate their subsequent wholesale availability to the organism via the
bloodstream. We also have to remember that, amongst other factors, evaporation
from fragrances applied to the dermis, limits their bioavailability, and that
the absorption of terpenes is influenced by the vehicle in which they are
applied (Cal 2006) as well as matrix effects etc.

Returning to the main
subject, further, Henley et al. do not eliminate the effects of other
hormone-disrupting chemicals from diet, home & environmental exposure to
chemicals or from other components in the cosmetics used. Further, they do not
explore whether other materials (vegetable oils, soya products etc.) are capable
of also producing the observed reactions.
Cropwatch has already reviewed the alleged estrogenic effects of essential oils
from the scientific literature (Cropwatch 2006) after Henley et al.
presented the same findings earlier to the Endocrine Society (Henley et al.
2006). Here Cropwatch found some evidence that some terpenes & derivatives
weakly interact with estrogen receptors under certain conditions (e.g. Howes
et al 2002) but little overall evidence for any specific & relevant
estrogenic effects for lavender & tea tree oil. It is difficult, therefore, to
explain the results of Henley et al. (if confirmed) from our existing
knowledge of essential oil composition, bioabsorption, pharmakinetics and human
physiological metabolic processes. Certainly, if true, a scientifically robust
confirmation of these findings would have serious implications for essential oil
& fragrance usage – the occurrence of linalool for example, is ubiquitous in
commodities derived from aromatic plants. However many of us who have spent a
lifetime working with natural aromatic products are a very long way from
accepting that this sequence of anecdotes & observations as currently presented,
even adds up to a hypothesis, let alone a theory. We will reserve judgment until
we see some properly designed scientifically rigorous studies, which, we
understand are already underway.

Peru
balsam producers in El Salvador have reported declining demand in recent years
which is threatening the quality of life of local balsam gatherers and the
infrastructure of local communities dependent on this income source, and the
viability of the actual Peru balsam forest itself (see
http://www.cropwatch.org/peru2.htm). Much of this production volume decline
stems from the banning of Peru balsam as a perfume ingredient by IFRA in 1982,
and the unprofessional regulatory muddle which recently engulfed the EU
Commission & its advisers in attempting to move PB qualities into an Annex of
the Cosmetics Directory (see
http://www.cropwatch.org/peru.htm & update). As a result of this, a
completely confused fragrance industry has many instances dropped Peru balsam
qualities from their raw material inventories.

A more technically
competent EU administration might have sought to find a way to work with
industry to manufacture a product with fewer adverse dermatological effects –
from purely humanitarian considerations if nothing else - since it has played a
part in the actual hardship which ensued. Cropwatch, with its limited resources,
thinks that manufacturing such a product might be feasible (see article link
above), and is seeking funds for the El Salvadorian Peru balsam industry, to try
to help it devise such a process.

Meanwhile Cropwatch is
not expecting a favourable reaction to its report in support of the Peru Balsam
industry in El Salvador from DG Enterprise. This is because the scope of the
Public Consultation was so narrow that the actual term “Public Consultation” is
quite derisory in our opinion, and Cropwatch was forced to go beyond its limits.
Further, the period allowed for submissions was so short (with Xmas & New Year
intervening) that a properly representational document was impossible to
assemble.